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Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

NCT ID: NCT00317473

Last Updated: 2017-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-07-31

Brief Summary

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To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months

Detailed Description

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Study consists of 3 cohorts (12 to 23 months, 24 to 35 months, and 36 to 47 months). Within each cohort subjects were randomized in a 2:1 ration to receive one of three dose levels of FMP1/AS02A (Cohort A, 10 ug; Cohort B, 25 ug; Cohort C, 50 ug) or Imovax Rabies vaccine. Immunization was staggered among dose cohorts; subjects in Cohort B received their first immunization only after the Local Medical Monitor and Data Safety Monitoring Board reviewed Cohort A safety data for the eight-day follow-up period following their first immunization. The same procedure was followed for the immunization of Cohort C. This will be conducted in western Kenya a the Walter Reed Project Lumbewa Clinic.

Conditions

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Plasmodium Falciparum Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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FMP1/AS02A Malaria vaccine 10ug

Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57

Group Type EXPERIMENTAL

FMP1/AS02A Malaria vaccine

Intervention Type BIOLOGICAL

Subjects vaccinated with FMP1/AS02 vaccine

FMP1/AS02A Malaria vaccine 25 ug

Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70

Group Type EXPERIMENTAL

FMP1/AS02A Malaria vaccine

Intervention Type BIOLOGICAL

Subjects vaccinated with FMP1/AS02 vaccine

FMP1/AS02A Malaria vaccine 50 ug

Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84

Group Type EXPERIMENTAL

FMP1/AS02A Malaria vaccine

Intervention Type BIOLOGICAL

Subjects vaccinated with FMP1/AS02 vaccine

Imovax Rabies Vaccine

Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days

Group Type ACTIVE_COMPARATOR

Imovax Rabies vaccine

Intervention Type BIOLOGICAL

Subjects vaccinated on corresponding FMP1/AS02A vaccination days

Interventions

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FMP1/AS02A Malaria vaccine

Subjects vaccinated with FMP1/AS02 vaccine

Intervention Type BIOLOGICAL

Imovax Rabies vaccine

Subjects vaccinated on corresponding FMP1/AS02A vaccination days

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A healthy male or female child, 12 to 47 months of age at the time of screening.
* Written informed consent obtained from at least one parent before study start.
* Available to participate for the duration of the study (12 months).

Exclusion Criteria

* Acute disease at the time of entry into the study
* Axillary temperature of 37.5 degrees C
* Respiratory rate 50
* Serum ALT 45 IU/l (i.e., \> 1.5 X ULN)
* Decreased renal function: serum creatinine levels \> 92.2 mM/l (\> 1.1 mg/dl).
* Significant anemia (Hgb \<8 gm/dL).
* Thrombocytopenia (Platelets \< 100,000 per mm3)
* Impaired immunity: (Absolute lymphocyte count \[ALC\] for 1 year olds \< 4.0 x 103/mm3; for 2 year olds \< 3.0 x 103/mm3; for 3 year olds \< 2.0 103/mm3.
* History of homozygous sickle cell disease (SS).
* Malnutrition (Z score; Malnutrition = Weight for height \< - 3 z scores)
* Blood transfusion or use of blood-based product in previous 6 months.
* Prior receipt of a rabies vaccine or an investigational malaria vaccine.
* Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
* Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For cortico-steroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
* Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
* Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV testing will be undertaken as part of this study.)
* History of allergic reactions or anaphylaxis to immunizations or to any vaccine components.
* History of surgical splenectomy.
* Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Simultaneous participation in any other clinical trial.
* Acute or chronic cardiovascular, pulmonary, hepatic or renal condition, which in the opinion of the PI may increase the risk to the subject from participating in the study.
* Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject.
Minimum Eligible Age

12 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role collaborator

The PATH Malaria Vaccine Initiative (MVI)

OTHER

Sponsor Role collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark R. Withers, M.D., MPH

Role: PRINCIPAL_INVESTIGATOR

USAMRU-K

Locations

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Walter Reed Project Kombewa Clinic

Kombewa, Nyanza Province, Kenya

Site Status

Countries

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Kenya

References

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Pichyangkul S, Gettayacamin M, Miller RS, Lyon JA, Angov E, Tongtawe P, Ruble DL, Heppner DG Jr, Kester KE, Ballou WR, Diggs CL, Voss G, Cohen JD, Walsh DS. Pre-clinical evaluation of the malaria vaccine candidate P. falciparum MSP1(42) formulated with novel adjuvants or with alum. Vaccine. 2004 Sep 28;22(29-30):3831-40. doi: 10.1016/j.vaccine.2004.07.023.

Reference Type BACKGROUND
PMID: 15364429 (View on PubMed)

Ockenhouse CF, Angov E, Kester KE, Diggs C, Soisson L, Cummings JF, Stewart AV, Palmer DR, Mahajan B, Krzych U, Tornieporth N, Delchambre M, Vanhandenhove M, Ofori-Anyinam O, Cohen J, Lyon JA, Heppner DG; MSP-1 Working Group. Phase I safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine. Vaccine. 2006 Apr 5;24(15):3009-17. doi: 10.1016/j.vaccine.2005.11.028. Epub 2005 Nov 28.

Reference Type BACKGROUND
PMID: 16356603 (View on PubMed)

Stoute JA, Gombe J, Withers MR, Siangla J, McKinney D, Onyango M, Cummings JF, Milman J, Tucker K, Soisson L, Stewart VA, Lyon JA, Angov E, Leach A, Cohen J, Kester KE, Ockenhouse CF, Holland CA, Diggs CL, Wittes J, Heppner DG Jr; MSP-1 Malaria Vaccine Working Group. Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya. Vaccine. 2007 Jan 2;25(1):176-84. doi: 10.1016/j.vaccine.2005.11.037. Epub 2005 Dec 7.

Reference Type BACKGROUND
PMID: 16388879 (View on PubMed)

Angov E, Aufiero BM, Turgeon AM, Van Handenhove M, Ockenhouse CF, Kester KE, Walsh DS, McBride JS, Dubois MC, Cohen J, Haynes JD, Eckels KH, Heppner DG, Ballou WR, Diggs CL, Lyon JA. Development and pre-clinical analysis of a Plasmodium falciparum Merozoite Surface Protein-1(42) malaria vaccine. Mol Biochem Parasitol. 2003 May;128(2):195-204. doi: 10.1016/s0166-6851(03)00077-x.

Reference Type RESULT
PMID: 12742586 (View on PubMed)

Other Identifiers

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HSRRB Log No. A-12094

Identifier Type: OTHER

Identifier Source: secondary_id

KEMRI SSC No. 761

Identifier Type: OTHER

Identifier Source: secondary_id

HSPC No. HS171

Identifier Type: OTHER

Identifier Source: secondary_id

WRAIR 1030

Identifier Type: -

Identifier Source: org_study_id